ES2525648T3 - Formulaciones galénicas que comprenden Aliskiren - Google Patents

Formulaciones galénicas que comprenden Aliskiren Download PDF

Info

Publication number: ES2525648T3
Authority: ES; Spain
Prior art keywords: aliskiren; minitableta; coating; core; galenic formulations
Prior art date: 2009-01-28
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Active

Application number

ES10702092.7T

Other languages

English (en)

Spanish (es)

Inventor

Sabine DESSET-BRÈTHES

Stefan Hirsch

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Novartis AG

Original Assignee

Novartis AG

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2009-01-28

Filing date

2010-01-27

Publication date

2014-12-26

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40770648&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2525648(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2010-01-27 Application filed by Novartis AG filed Critical Novartis AG

2014-12-26 Application granted granted Critical

2014-12-26 Publication of ES2525648T3 publication Critical patent/ES2525648T3/es

Status Active legal-status Critical Current

2030-01-27 Anticipated expiration legal-status Critical

Links

229960004601 aliskiren Drugs 0.000 title abstract description 5
UXOWGYHJODZGMF-QORCZRPOSA-N Aliskiren Chemical compound COCCCOC1=CC(C[C@@H](C[C@H](N)[C@@H](O)C[C@@H](C(C)C)C(=O)NCC(C)(C)C(N)=O)C(C)C)=CC=C1OC UXOWGYHJODZGMF-QORCZRPOSA-N 0.000 title abstract description 4
239000000203 mixture Substances 0.000 title abstract description 3
238000009472 formulation Methods 0.000 title description 2
239000011248 coating agent Substances 0.000 abstract 4
238000000576 coating method Methods 0.000 abstract 4
229920006243 acrylic copolymer Polymers 0.000 abstract 1
229920002678 cellulose Polymers 0.000 abstract 1
239000001913 cellulose Substances 0.000 abstract 1
230000000873 masking effect Effects 0.000 abstract 1
239000000463 material Substances 0.000 abstract 1
229920000058 polyacrylate Polymers 0.000 abstract 1
150000003839 salts Chemical class 0.000 abstract 1
239000007892 solid unit dosage form Substances 0.000 abstract 1
KLRSDBSKUSSCGU-KRQUFFFQSA-N aliskiren fumarate Chemical compound OC(=O)\C=C\C(O)=O.COCCCOC1=CC(C[C@@H](C[C@H](N)[C@@H](O)C[C@@H](C(C)C)C(=O)NCC(C)(C)C(N)=O)C(C)C)=CC=C1OC.COCCCOC1=CC(C[C@@H](C[C@H](N)[C@@H](O)C[C@@H](C(C)C)C(=O)NCC(C)(C)C(N)=O)C(C)C)=CC=C1OC KLRSDBSKUSSCGU-KRQUFFFQSA-N 0.000 description 1
239000002775 capsule Substances 0.000 description 1
239000007963 capsule composition Substances 0.000 description 1
239000012669 liquid formulation Substances 0.000 description 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives

Landscapes

Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
Chemical & Material Sciences (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
Life Sciences & Earth Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Epidemiology (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Chemical Kinetics & Catalysis (AREA)
Organic Chemistry (AREA)
Cardiology (AREA)
Biomedical Technology (AREA)
Heart & Thoracic Surgery (AREA)
Neurosurgery (AREA)
Neurology (AREA)
Urology & Nephrology (AREA)
Diabetes (AREA)
Hospice & Palliative Care (AREA)
Hematology (AREA)
Obesity (AREA)
Endocrinology (AREA)
Emergency Medicine (AREA)
Pain & Pain Management (AREA)
Psychiatry (AREA)
Vascular Medicine (AREA)
Medicinal Preparation (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

ES10702092.7T 2009-01-28 2010-01-27 Formulaciones galénicas que comprenden Aliskiren Active ES2525648T3 (es)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
EP09151496		2009-01-28
EP09151496		2009-01-28
PCT/EP2010/050886 WO2010086312A1 (fr)	2009-01-28	2010-01-27	Formulations galéniques de composés organiques

Publications (1)

Publication Number	Publication Date
ES2525648T3 true ES2525648T3 (es)	2014-12-26

Family

ID=40770648

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
ES10702092.7T Active ES2525648T3 (es)	2009-01-28	2010-01-27	Formulaciones galénicas que comprenden Aliskiren

Country Status (27)

Country	Link
US (1)	US20110287100A1 (fr)
EP (1)	EP2391345B1 (fr)
JP (1)	JP2012516299A (fr)
KR (1)	KR20110117199A (fr)
CN (1)	CN102300558A (fr)
AR (1)	AR075179A1 (fr)
AU (1)	AU2010209787B2 (fr)
BR (1)	BRPI1007452A2 (fr)
CA (1)	CA2749531A1 (fr)
CL (1)	CL2011001817A1 (fr)
CO (1)	CO6400184A2 (fr)
EC (1)	ECSP11011289A (fr)
ES (1)	ES2525648T3 (fr)
IL (1)	IL213918A0 (fr)
MA (1)	MA33060B1 (fr)
MX (1)	MX2011007779A (fr)
MY (1)	MY153852A (fr)
NZ (1)	NZ593622A (fr)
PE (1)	PE20110943A1 (fr)
PL (1)	PL2391345T3 (fr)
PT (1)	PT2391345E (fr)
RU (1)	RU2535090C2 (fr)
SG (1)	SG172226A1 (fr)
TN (1)	TN2011000307A1 (fr)
TW (1)	TWI468191B (fr)
WO (1)	WO2010086312A1 (fr)
ZA (1)	ZA201104489B (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JP5822758B2 (ja) *	2011-03-02	2015-11-24	第一三共ヘルスケア株式会社	速溶性防湿フィルムコーティング製剤及びその製造方法
EP2596802A1 (fr) *	2011-11-23	2013-05-29	PLS-Design GmbH	Composition pharmaceutique pour le traitement des réactions allergiques
HRP20250913T1 (hr) *	2016-02-03	2025-09-26	Novartis Ag	Nova upotreba kombinacije sakubitrila i valsartana
US12171878B2 (en)	2018-08-10	2024-12-24	Kissei Pharmaceutical Co., Ltd.	Sucroferric oxyhydroxide-containing granules and pharmaceutical composition
GB2585413B (en)	2019-02-22	2023-04-26	Catalent Uk Swindon Zydis Ltd	Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
WO2020169989A1 (fr)	2019-02-22	2020-08-27	Catalent U.K. Swindon Zydis Limited	Réduction au minimum de l'agglomération, de l'aération et préservation du revêtement de compositions pharmaceutiques comprenant de l'ibuprofène
TWI849062B (zh)	2019-02-22	2024-07-21	英商康泰倫特英國斯文敦載迪斯有限公司	保存水性懸浮液中以無溶劑混合方法製備的功能性塗覆之活性醫藥成份微粒
CN113507923B (zh)	2019-02-22	2024-03-26	康特伦英国斯温顿捷迪斯有限公司	在线混合期间混悬液的曝气最小化
WO2021011538A1 (fr) *	2019-07-15	2021-01-21	R.P. Scherer Technologies, Llc	Formes galéniques capsules, leurs procédés de préparation et leurs procédés d'utilisation
BR112023001716A2 (pt)	2020-07-31	2023-04-04	Catalent Uk Swindon Zydis Ltd	Composições farmacêuticas compreendendo api revestido
CN116887866A (zh)	2020-12-03	2023-10-13	巴特尔纪念研究院	聚合物纳米颗粒和dna纳米结构组合物及用于非病毒递送的方法
JP2024516108A (ja)	2021-04-07	2024-04-12	バテル・メモリアル・インスティテュート	非ウイルス性担体を同定および使用するための迅速な設計、構築、試験、および学習技術
WO2025072751A1 (fr)	2023-09-29	2025-04-03	Battelle Memorial Institute	Compositions de nanoparticules polymères pour l'expression in vivo de polypeptides
TW202523280A (zh) *	2023-11-17	2025-06-16	日商第一三共健康事業股份有限公司	固體製劑
US12441996B2 (en)	2023-12-08	2025-10-14	Battelle Memorial Institute	Use of DNA origami nanostructures for molecular information based data storage systems

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
MY119161A (en)	1994-04-18	2005-04-30	Novartis Ag	Delta-amino-gamma-hydroxy-omega-aryl-alkanoic acid amides with enzyme especially renin inhibiting activities
DE19842753A1 (de) *	1998-09-18	2000-03-23	Bayer Ag	Agitationsunabhängige pharmazeutische Retardzubereitungen und Verfahren zu ihrer Herstellung
US6248363B1 (en) *	1999-11-23	2001-06-19	Lipocine, Inc.	Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
AR034813A1 (es) *	2001-07-20	2004-03-17	Novartis Ag	Composiciones farmaceuticas y uso de las mismas
WO2004100871A2 (fr) *	2003-05-09	2004-11-25	Pharmacia Corporation	Combinaison d'un antagoniste du recepteur de l'aldosterone et d'un inhibiteur de renine
AR048431A1 (es)	2004-03-17	2006-04-26	Novartis Ag	Formulaciones galenicas de compuestos organicos
WO2005105054A1 (fr) *	2004-04-15	2005-11-10	Dr. Reddy's Laboratories Ltd.	Forme de dosage ayant une stabilité polymorphique
EP2248520A3 (fr) *	2004-10-08	2010-11-17	Novartis AG	Utilisation d'inhibiteurs de rénine pour la prévention ou le traitement du dysfonctionnement diastolique ou de la cardiopathie diastolique
WO2009045796A1 (fr) *	2007-09-28	2009-04-09	Novartis Ag	Combinaison pharmaceutique d'aliskirène et de valsartane

2010
- 2010-01-27 CN CN2010800057033A patent/CN102300558A/zh active Pending
- 2010-01-27 KR KR1020117019809A patent/KR20110117199A/ko not_active Ceased
- 2010-01-27 WO PCT/EP2010/050886 patent/WO2010086312A1/fr not_active Ceased
- 2010-01-27 PE PE2011001391A patent/PE20110943A1/es not_active Application Discontinuation
- 2010-01-27 PL PL10702092T patent/PL2391345T3/pl unknown
- 2010-01-27 PT PT107020927T patent/PT2391345E/pt unknown
- 2010-01-27 ES ES10702092.7T patent/ES2525648T3/es active Active
- 2010-01-27 MA MA34114A patent/MA33060B1/fr unknown
- 2010-01-27 JP JP2011546822A patent/JP2012516299A/ja active Pending
- 2010-01-27 AU AU2010209787A patent/AU2010209787B2/en not_active Ceased
- 2010-01-27 SG SG2011044450A patent/SG172226A1/en unknown
- 2010-01-27 RU RU2011135417/15A patent/RU2535090C2/ru not_active IP Right Cessation
- 2010-01-27 AR ARP100100193A patent/AR075179A1/es unknown
- 2010-01-27 MX MX2011007779A patent/MX2011007779A/es not_active Application Discontinuation
- 2010-01-27 TW TW99102290A patent/TWI468191B/zh not_active IP Right Cessation
- 2010-01-27 NZ NZ593622A patent/NZ593622A/en not_active IP Right Cessation
- 2010-01-27 EP EP10702092.7A patent/EP2391345B1/fr not_active Not-in-force
- 2010-01-27 BR BRPI1007452A patent/BRPI1007452A2/pt not_active IP Right Cessation
- 2010-01-27 US US13/145,454 patent/US20110287100A1/en not_active Abandoned
- 2010-01-27 CA CA2749531A patent/CA2749531A1/fr not_active Abandoned
- 2010-01-27 MY MYPI2011003186A patent/MY153852A/en unknown
2011
- 2011-06-16 TN TN2011000307A patent/TN2011000307A1/fr unknown
- 2011-06-17 ZA ZA2011/04489A patent/ZA201104489B/en unknown
- 2011-07-04 IL IL213918A patent/IL213918A0/en unknown
- 2011-07-27 CL CL2011001817A patent/CL2011001817A1/es unknown
- 2011-07-28 CO CO11095153A patent/CO6400184A2/es not_active Application Discontinuation
- 2011-08-26 EC EC2011011289A patent/ECSP11011289A/es unknown

Also Published As

Publication number	Publication date
CL2011001817A1 (es)	2012-01-13
PL2391345T3 (pl)	2015-03-31
JP2012516299A (ja)	2012-07-19
TN2011000307A1 (en)	2012-12-17
CN102300558A (zh)	2011-12-28
MA33060B1 (fr)	2012-02-01
TW201038300A (en)	2010-11-01
AR075179A1 (es)	2011-03-16
PT2391345E (pt)	2014-12-03
AU2010209787B2 (en)	2013-06-06
EP2391345A1 (fr)	2011-12-07
TWI468191B (zh)	2015-01-11
IL213918A0 (en)	2011-07-31
NZ593622A (en)	2013-12-20
MY153852A (en)	2015-03-31
US20110287100A1 (en)	2011-11-24
ECSP11011289A (es)	2011-09-30
PE20110943A1 (es)	2012-01-22
BRPI1007452A2 (pt)	2016-02-16
MX2011007779A (es)	2011-08-12
CO6400184A2 (es)	2012-03-15
WO2010086312A1 (fr)	2010-08-05
KR20110117199A (ko)	2011-10-26
AU2010209787A1 (en)	2011-07-14
SG172226A1 (en)	2011-07-28
CA2749531A1 (fr)	2010-08-05
EP2391345B1 (fr)	2014-09-03
RU2011135417A (ru)	2013-03-10
RU2535090C2 (ru)	2014-12-10
ZA201104489B (en)	2012-02-29
HK1161125A1 (en)	2012-08-24

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